MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Pyrantel Pamoate SuspensionTrade Name:COMBANTRINC hemical Family:TetrahydropyrimidineIntended Use:Pharmaceutical product used as anti-worm agent (anthelmintic)2. HAZARDS IDENTIFICATIONA ppearance:Liquid suspensionStatement of Hazard:Non-hazardous in accordance with international standards for workplace Term:May cause mild eye irritation. (based on components) .Long Term:Repeat-dose studies in animals have shown a potential to cause adverse effects ongastrointestinal system, Clinical Effects:Ingestion of this MATERIAL may cause effects similar to those seen in clinical use includingnausea, vomiting, abdominal cramps, anorexia, diarrhea, and constipation. Occasional,transient changes reported in liver function tests, but no liver damage Indication of danger:Not classifiedAustralian Hazard Classification(NOHSC):Non-Hazardous Substance.

2 Non-Dangerous :This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS ListClassification%Pyrantel pamoate22204-24-6244-837-1 Not Listed5 Lecithin8002-43-5232-307-2 Not Listed*Glycerin, USP56-81-5200-289-5 Not Listed*Magnesium aluminum silicate1327-43-1215-478-8 Not Listed*_____PZ00929 Revision date: 12-Mar-2010 Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322 Contact MATERIAL SAFETY data SHEETPage 1 of 7 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 Pfizer Ltd,KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours).

3 1-800-424-9300 MATERIAL SAFETY data SHEET_____IngredientCAS NumberEU EINECS/ELINCS ListClassification%Citric acid monohydrate5949-29-1 Not listedNot Listed*Povidone9003-39-8 Not listedNot Listed*Sodium benzoate532-32-1208-534-8 Not Listed*Sorbitol6706-59-8 Not listedNot Listed*Polysorbate 809005-65-6 Not listedNot Listed*FlavorNOT ASSIGNEDNot listedNot Listed*Water, purified7732-18-5231-791-2 Not Listed*Antifoam EmulsionMixtureNot listedNot Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes. Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap.

4 Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention and Effects of Exposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Combustion Products:Formation of toxic gases is possible during heating or Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:Fine particles (such as dust and mists) may fuel ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8).

5 Minimize for Cleaning / Collecting:Contain the source of spill if it is safe to do so. Collect spill with absorbent MATERIAL . Clean spillarea for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental Consideration for LargeSpills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained date: 12-Mar-2010 MATERIAL Name: Pyrantel Pamoate SuspensionVersion: 2 of 7 MATERIAL SAFETY data SHEET_____7. HANDLING AND STORAGEG eneral Handling:Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, useappropriate personal protective equipment (see Section 8).

6 Wash hands and any exposed skinafter removal of PPE. Releases to the environment should be avoided. Review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure or environmental releases. Potential points of process emissions of thismaterial to the atmosphere should be controlled with dust collectors, HEPA filtration systems orother equivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure Method:Analytical method available for pyrantel pamoate. Contact Pfizer Inc for further Controls:Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes.

7 Keep airbornecontamination levels below the exposure limits listed above in this Exposure Controls:Refer to specific Member State legislation for requirements under Community Protective Equipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).Hands:Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing :Wear SAFETY glasses or goggles if eye contact is :Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the - Final PELS - TWAs:15 mg/m3 total5 mg/m3 Version.

8 OEL - TWAL istedAustralia TWA10 mg/m3 Portugal OEL - TWAL istedPyrantel pamoateSpain OEL - TWAL istedBelgium OEL - TWAM agnesium aluminum silicateListedBulgaria OEL - TWAL istedPage 3 of 7 Czech Republic OEL - TWAL istedCzech Republic OEL - TWAL istedPfizer OEL TWA-8 Hr:Estonia OEL - TWAL isted300 g/m3 Finland OEL - TWAL istedFrance OEL - TWAL istedGlycerin, USPR evision date: 12-Mar-2010 Germany (DFG) - MAK50 mg/m3 MAKM aterial Name: Pyrantel Pamoate SuspensionGreece OEL - TWAL istedACGIH Threshold Limit Value (TWA)10 mg/m3 TWAI reland OEL - TWAsListed MATERIAL SAFETY data SHEET_____9. PHYSICAL AND CHEMICAL PROPERTIESP olymerization:Will not occur10. STABILITY AND REACTIVITYS tability:Stable under normal conditions of to Avoid:Fine particles (such as dust and mists) may fuel Materials:As a precautionary measure, keep away from strong oxidizers11.

9 TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the : Dermal LD 50 > g/kgMolecular Weight:MixturePolysorbate 80 Sodium benzoateRat Oral LD50 25 g/kgPage 4 of 7 LecithinRat Oral LD50 4,070 mg/kgRat Oral LD50 > 8 ml/kgPyrantel pamoateRevision date: 12-Mar-2010 Mouse Oral LD50 1600 mg/kgMouse Oral LD50 > 24 g/kgPhysical State:Rat Oral LD50 > 24 g/kgSuspensionGlycerin, USPM ouse Intraperitoneal LD50 620 mg/kgRat Intraperitoneal LD50 535 mg/kgMaterial Name: Pyrantel Pamoate SuspensionMouse Oral LD50 4090 mg/kgPovidoneColor:Rat Oral LD50 100 g/kgNo data Oral LD50 g/kgRabbit Dermal LD50 > 10 g/kgMolecular Formula:MixtureRat Inhalation LC50 1hr > 570 mg/m3 MATERIAL SAFETY data SHEET_____11.

10 TOXICOLOGICAL INFORMATIONI rritation / Sensitization: (Study Type, Species, Severity)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:Environmental properties have not been thoroughly investigated. Releases to the environmentshould be Toxicity: (Species, Method, End Point, Duration, Result)Aquatic Toxicity Comments:A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximumdose / Fetal Development Rat Oral 250 mg/kg NOAEL Not TeratogenicCitric acid monohydrateEmbryo / Fetal Development Rabbit Oral 250 mg/kg NOAEL Not TeratogenicPyrantel pamoateVersion.